FDA.reportPublic FDA data

Application 205613

Type
NDA
Sponsor
SALIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001UCERISBUDESONIDEAEROSOL, FOAM;RECTAL2MG/ACTUATIONYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
65649-651UcerisbudesonideSalix Pharmaceuticals, Inc.NDACurrent
68682-658budesonidebudesonideOceanside PharmaceuticalsNDACurrent
68682-658budesonidebudesonideOceanside PharmaceuticalsNDACurrent
68682-658budesonidebudesonideOceanside PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62559SUPPL2020-04-14
62530SUPPL2020-04-10
44926ORIG2015-07-02
43495ORIG2015-07-02
19667ORIG2014-10-09
10477ORIG2014-10-08
32694ORIG2014-09-17